Achilles Insight Bone Sonometer — Class II medical device recall Z-0112-2020
Terminated recall by GE Healthcare, LLC, reported 2019-10-16, distributed nationwide. Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to c
| Recall number | Z-0112-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-09-03 |
| Classified | 2019-10-10 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2021-02-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BD, BH, BR, CH, CL, CN, CO, CY, GB, HK, IE, IN, IQ, IT, KW, LB, LK, MX, MY, NP, OM, PA, PE, PH, SA, SG, TH, TW, UY, VN |
| Quantity | 599 devices |
| UPC / GTIN / UDI-DI | 83033005100157, 83033602003714 |
Product
Achilles Insight Bone Sonometer
Reason for recall
Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0112-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.